US2003225000A1PendingUtilityA1

Stabilized teriparatide solutions

62
Priority: Dec 9, 1997Filed: Apr 30, 2003Published: Dec 4, 2003
Est. expiryDec 9, 2017(expired)· nominal 20-yr term from priority
Inventors:Chin-Ming ChangHenry Havel
A61K 47/10A61K 9/0019A61K 38/29A61K 47/26A61K 9/19
62
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

A stabilized pharmaceutical composition in the form of a solution for parenteral administration of a parathyroid hormone is described wherein the therapeutically active ingredient is stabilized with a buffer and a polyol. Preferred preparations contain in an aqueous solution human PTH(1-34), mannitol, an acetate or tartrate buffering agent and m-cresol or benzyl alcohol as a preservative.

Claims

exact text as granted — not AI-modified
We claim:  
     
         1 . A parathyroid hormone solution comprising: 
 (a) a therapeutically effective amount of a parathyroid hormone;    (b) an effective amount of a stabilizing agent;    (c) a buffering agent in an amount sufficient to maintain the pH of the composition within a range of about 3-7; and    (d) the balance being water.    
     
     
         2 . The solution of  claim 1 , wherein the hormone is a fragmented hormone selected from the group consisting of PTH(1-34), PTH(1-37), PTH(1-38), and PTH(141).  
     
     
         3 . The solution of  claim 1 , wherein the hormone is human PTH(1-34) (SEQ ID NO: 2).  
     
     
         4 . The solution of  claim 1 , wherein the hormone is human PTH(1-84) (SEQ ID NO: 1).  
     
     
         5 . The solution of  claim 1 , wherein the stabilizing agent is a polyol.  
     
     
         6 . The solution of  claim 5 , wherein the polyol is mannitol.  
     
     
         7 . The solution of  claim 5 , wherein the polyol is propylene glycol.  
     
     
         8 . The solution of  claim 1 , wherein the buffering agent is an acetate or tartrate source.  
     
     
         9 . The solution of  claim 8 , wherein the buffering agent is acetate.  
     
     
         10 . The solution of  claim 1 , which further comprises a parenterally acceptable preservative.  
     
     
         11 . The solution of  claim 10 , wherein the preservative is m-cresol or benzyl alcohol.  
     
     
         12 . The solution of  claim 11 , wherein the preservative is m-cresol.  
     
     
         13 . A composition according to  claim 1 , in the form of a freeze-dried powder containing less than 2% water by weight.  
     
     
         14 . A parathyroid hormone solution comprising: 
 (a) a therapeutically effective amount of a parathyroid hormone;    (b) from about 1 to 20 wt-% of a stabilizing agent;    (c) a buffering agent in an amount sufficient to maintain the pH of the composition within a range of about 3-7 and selected from an acetate or tartrate source;    (d) from about 0.1 to 2 wt-% of a parenterally acceptable preservative; and    (e) the balance being water.    
     
     
         15 . The solution of  claim 14 , wherein the hormone is PTH(1-84).  
     
     
         16 . The solution of  claim 14 , wherein the hormone is selected from the group consisting of PTH(1-34), PTH(1-37), PTH(1-38), and PTH(1-41).  
     
     
         17 . The solution of  claim 16 , wherein the hormone is human PTH(1-34) (SEQ ID NO: 2).  
     
     
         18 . The solution of  claim 14 , wherein the stabilizing agent is a polyol in an amount of about 3 to about 10 wt-%.  
     
     
         19 . The solution of  claim 14 , wherein the preservative is m-cresol or benzylalcohol in an amount of about 0.3 to about 1.0 wt-%.  
     
     
         20 . A pharmaceutical composition in the form of a freeze-dried powder comprising: 
 (a) a therapeutically effective amount of a fragmented parathyroid hormone selected from the group consisting of PTH(1-34), PTH(1-37), PTH(1-38), and PTH(1-41);    (b) an effective amount of a stabilizing agent;    (c) a buffering agent in an amount sufficient to maintain the pH of the composition within a range of about 3-7; and    (d) less than 2 wt-% water by weight.    
     
     
         21 . The composition of  claim 20 , wherein the hormone is human PTH(1-34) (SEQ ID NO: 2).  
     
     
         22 . The composition of  claim 20 , wherein the stabilizing agent is selected from the group consisting of glycine, mannitol, sucrose, trehalose, raffinose and a mixture thereof.  
     
     
         23 . The composition of  claim 20 , wherein the buffering agent is an acetate or tartrate source.  
     
     
         24 . The composition of  claim 23 , wherein the buffering agent is a tartrate source.  
     
     
         25 . The composition of  claim 20 , wherein the stabilizing agent is in an amount of about 1 to about 20 wt-%.

Join the waitlist — get patent alerts

Track US2003225000A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.